Reported Oct 14, 2015 · Terminated
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
CooperSurgical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 75 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
- Lot codes and dates
- LOT 187889
- Amount recalled
- 305 units
Where it was sold
Why it was recalled
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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