StatLock CV Plus w/Pigtail — Class II medical device recall Z-1618-2013
Terminated recall by Bard Access Systems, reported 2013-07-10. BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incor
| Recall number | Z-1618-2013 |
|---|---|
| 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 | 2013-06-10 |
| Classified | 2013-06-28 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2014-05-21 |
| Countries outside the US | AR, BR, CN |
| Quantity | 3,875 units |
| Lot numbers | JUWJF283 |
Product
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
Reason for recall
BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
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-1618-2013. 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.