Z-1053-2013 Class II Terminated
FDA device recall Z-1053-2013 was initiated by Cooper Surgical, Inc. on February 26, 2013 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated June 12, 2014). Affected quantity: 4395 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2013
- Initiation Date
- February 26, 2013
- Termination Date
- June 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4395 kits
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.
Reason for Recall
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 Pattern
Nationwide Distribution including Puerto Rico
Code Information
Lot 120716, exp 8-31-13; Lot 116657 exp. 6-30-13; Lot 116658 exp. 5-31-13; Lot 116659 exp. 7-31-13