StatLock¿ PICC Plus Crescent Foam — Class II medical device recall Z-0981-2017
Terminated recall by Bard Access Systems, reported 2017-01-18, distributed nationwide. Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices becaus
| Recall number | Z-0981-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Salt Lake City, UT, United States |
| Recall initiated | 2016-12-09 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 30,000 units |
| Lot numbers | JUAQF020, JUZGF345 |
Product
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Reason for recall
Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0981-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.