PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported March 25, 2015

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to so…

Recall #
Z-1271-2015
Affected scope
134,554 units
Initiated
August 8, 2014
Compiled from official public sources by the publisher.
Verify with FDA Devices →
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Bard Access Systems recalled BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly … - a moderate-severity action.

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly … was recalled by Bard Access Systems in March 25, 2015. Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact p…. Check the official notice for the remedy. Verify recall #Z-1271-2015 with the FDA Devices before acting.

The recall

Bard Access Systems issued this moderate-severity FDA Devices recall-Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact p….

Moderate
severity level
135K units
affected scope
Class II
classification
March 25, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1271-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L

Reason for recall

Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1271-2015
Date reported March 25, 2015
Date initiated August 8, 2014
Recalling firm Bard Access Systems
Firm location Salt Lake City, UT
Affected scope 134,554 units
Distribution US Nationwide Distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

134,554 units units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1271-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L. Recalled by Bard Access Systems. Units affected: 134,554 units.
Why was this product recalled? ▼
Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2015. Severity: Moderate. Recall number: Z-1271-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution..
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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