Recall Z-1618-2013 ยท KMK Device, Intravascular Catheter Securement
Bard Access Systems
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.
| Date | Jun 28, 2013 (initiated Jun 10, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Packaging |
| Action | On 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions. |
| Quantity | 3,875 units. |
| Distribution | National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.