CAREFREE KITTNER TAIL LONG 4" LONG 5PK 25PKS/CS
Received Jul 10, 2025 · Event occurred Jun 20, 2024
Report 2951379-2024-00001 · MDR key 22469675
Device
Generic name
Sterile Kittner Roll
Manufacturer
Carefree Surgical Specialties, IncModel number
15508/25Lot number
1595
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CUSTOMER REPORTED INCORRECT QUANTITY IN SKU 15508/25, LOT: 1595. PACKAGE LABELED AS 5-PACK CONTAINED 6 UNITS. THE PRODUCT WAS NOT USED AND NO PATIENT CONTACT OCCURRED. ROOT CAUSE DETERMINED TO BE OPERATOR OVERSIGHT DURING FINAL PACKAGING. STAFF WAS RETRAINED AND ADDITIONAL PACKAGING CHECKS IMPLEMENTED. A REPLACEMENT PRODUCT WAS SENT. DEVICE WAS NOT RETURNED FOR EVALUATION. A VOLUNTARY RECALL WILL BE INITIATED JULY 2025.
Description of Event or Problem
CUSTOMER IDENTIFIED THERE WAS WRONG QUANTITY FOUND WITHIN A KITTNER 5/PACK. THERE WAS A COUNT OF 6 INSTEAD OF 5.
Remedial action
- Replace