Recall Z-3188-2024— CooperSurgical, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperSurgical, Inc., initiated 2024-07-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Silver-Plated Copper Sims Uterine Sound, Part Number 64-600. Reason: During the manufacturing process the devices were laser-marked with the incorrect part number..
- Recalling firm
- CooperSurgical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-31
- Firm location
- Trumbull, CT, United States
Product description
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Reason for recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
Data sourced from openFDA. This site is unofficial and independent of the FDA.