Recall record at a glance
| Official record | Z-1053-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cooper Surgical, Inc. |
| Report date | Apr 10, 2013 |
| Recall initiation date | Feb 26, 2013 |
| Quantity | 4395 kits |
| Location | Trumbull, CT, United States |
Official product description
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.
Why the product 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).
Distribution information
Nationwide Distribution including Puerto Rico
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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