Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proc
FDA device recall Z-1495-2016 · posted 2016-04-14 · Terminated
Recall details
- Recalling firm
- Customed, Inc
- Reason for recall
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Action taken
- Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- OKV
- Quantity affected
- 30
- Distribution
- Distributed only in Puerto Rico.
- Date initiated
- 2016-01-07
- Date posted
- 2016-04-14
- Date terminated
- 2017-05-03
- Location
- Fajardo, PR
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