FDA Enforcement
Class II
Terminated
PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Recall: Z-2577-2015
·
Reported September 9, 2015
Enforcement
- Recall Number
- Z-2577-2015
- Event ID
- 71721
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 9, 2015
- Initiation Date
- July 10, 2015
- Classification Date
- September 3, 2015
- Termination Date
- April 12, 2017
- Address
- Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States
Description
PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code Info
Code:9001297 Lots: 141015609 exp. 10/31/15 141115976 exp. 11/30/15 150116757 exp. 2/28/16 150116758 exp. 2/28/16 150116756 exp. 2/28/16 150619380 exp. 6/30/16
Distribution
Distributed Only in Puerto Rico.
Quantity
390 packs