Recall Z-1331-2013 ยท FYE Dress, Surgical
DePuy Orthopaedics, Inc.
DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
| Date | May 16, 2013 (initiated May 8, 2013) |
| Status | Terminated |
| Reason | LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves. |
| Root cause | Labeling mix-ups |
| Action | DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.,sent a " Urgent Information Medical Device Recall Notice" dated May 8, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please cease further distribution or use of the affected gloves immediately. Our records indicate your hospital purchased the affected lot. The purpose of this communication is to inform you of this recall and request acknowledgement of receipt of this letter by signing and returning the Hospital/User Facility Reconcilia |
| Quantity | 180 gloves (120 gloves distributed in the US) |
| Distribution | Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.