Reported Apr 10, 2013 · Terminated
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop…
Cooper Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Cooper Surgical, Inc. · 75 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
- Lot codes and dates
Lot 120716exp 8-31-13Lot 116657 exp. 6-30-13Lot 116658 exp. 5-31-13Lot 116659 exp. 7-31-13
- Amount recalled
- 4395 kits
Where it was sold
- Nationwide
- PR
Why it was recalled
LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
This product could cause temporary or reversible health problems — stop using it.
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