—#117845

Product

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.

FDA product code: FYE — Dress, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot - D12178C

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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 Reconciliation Form within 10 business days of receiving this notice. Response cards should be faxed to (574) 371-4964. Please contact your DePuy Synthes Joint Reconstruction Sales Representative for assistance returning any unused affected gloves. For product related questions, please contact your local DePuy Synthes Joint Reconstruction Sales Consultant. For clinical questions from surgeons, please contact DePuy Synthes Joint Reconstructions Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.- 5 p.m. EDT). For questions about device recall information provided, please call (574)371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-05-08
Posted by FDA: 2013-05-16
Terminated: 2014-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117845. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.