CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Reported: October 14, 2015 Initiated: September 1, 2015 #Z-0105-2016
Product Description
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Reason for Recall
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 305 units
- Distribution
- US Distribution to the states of : AL, AZ, CA, GA, IA, IL, KS, LA, MA, MD, MN, MO, MS, NY, OH, PA, TN, TX, VA, and VT.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061. Recalled by CooperSurgical, Inc.. Units affected: 305 units.
Why was this product recalled? ▼
Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2015. Severity: Low. Recall number: Z-0105-2016.
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