Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 19, 2018
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Angiodynamics Inc. (Navilyst Medical Inc.) recalled BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP… - a moderate-severity action.
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP… was recalled by Angiodynamics Inc. (Navilyst Medical Inc.) in December 19, 2018. Reason: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The l…. Check the official notice for the remedy. Verify recall #Z-0596-2019 with the FDA Devices before acting.
The recall
Angiodynamics Inc. (Navilyst Medical Inc.) issued this moderate-severity FDA Devices recall-specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The l….
- Moderate
- severity level
- Class II
- classification
- December 19, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0596-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0596-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on October 16, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Angiodynamics Inc. (Navilyst Medical Inc.) is listed as the recalling firm, operating out of Glens Falls, NY. Federal records list the affected scope as Box of 4 units.
The documented reason for this recall is: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing… Distribution data in the federal record shows the product reached: Distributed to accounts in Florida. Foreign distribution to Great Britain.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
Box of 4 units
Related Recalls
6
3 from same agency
Product description
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Reason for recall
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0596-2019 |
| Date reported | December 19, 2018 |
| Date initiated | October 16, 2018 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Firm location | Glens Falls, NY |
| Affected scope | Box of 4 units |
| Distribution | Distributed to accounts in Florida. Foreign distribution to Great Britain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0596-2019) 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? ▼
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: Box of 4 units.
Why was this product recalled? ▼
specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0596-2019.
Where was the recalled product distributed? ▼
Distribution: Distributed to accounts in Florida. Foreign distribution to Great Britain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0596-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 19, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.