ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane
FDA device recall Z-1264-03 · posted 2003-09-23 · Terminated
Recall details
- Recalling firm
- International Surgical Supply, Inc.
- Reason for recall
- Various Sterile Expired and Non-expired Ethicon brand surgical devices were resterilized without adequate validations and distributed.
- Action taken
- The firm sent an e-mail recall notification and request for response on 9/3/2003, to the one direct account in Minnesota requesting quarantine and return of product and also subrecall down to the hospital/health professional level.
- Root cause
- Other
- Status
- Terminated
- Product code
- KDC
- Quantity affected
- 6 boxes of 6 each
- Distribution
- Product was distributed to a direct consignee/distributor in Minnesota and also directly to the only two hospital/health professional accounts involved both in Tennessee.
- Date initiated
- 2003-09-03
- Date posted
- 2003-09-23
- Date terminated
- 2012-05-06
- Location
- Miami, FL
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