FDA Devices recall · Reported December 20, 2017
Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central veno
Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on informat…
Angiodynamics Inc. (Navilyst Medical Inc.) recalled Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xc… - a moderate-severity action.
Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xc… was recalled by Angiodynamics Inc. (Navilyst Medical Inc.) in December 20, 2017. Reason: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioF…. Check the official notice for the remedy. Verify recall #Z-0245-2018 with the FDA Devices before acting.
The recall
Angiodynamics Inc. (Navilyst Medical Inc.) issued this moderate-severity FDA Devices recall-Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioF….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- December 20, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0245-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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
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
Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.
Reason for recall
Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0245-2018 |
| Date reported | December 20, 2017 |
| Date initiated | November 28, 2016 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Firm location | Glens Falls, NY |
| Affected scope | 4591 units in total |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain. |
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-0245-2018) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026