FDA Medical Device Recalls (openFDA)
Customed, Inc: Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Recall number
- Z-1489-2016
- Recalling firm
- Customed, Inc
- Product
- Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Status
- Terminated
- Initiated
- 2016-01-07
- Posted
- 2016-04-14
- Terminated
- 2017-05-03
- Reason
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Root cause
- Packaging
- Action
- Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
- Quantity
- 16
- Distribution
- Distributed only in Puerto Rico.
- Lot, serial or model codes
- LOTS: SL15173 (150418424) 30-JUN-16 SL15175 (150619376) 30-JUN-16 SL15176 (150619376) 30-JUN-16 SL15202 (150619296) 31-JUL-16 SL15202 (150619470) 31-JUL-16 SL15203 (150719296) 31-JUL-16 SL15208 (150719812) 31-JUL-16 SL15211 (150719812) 31-JUL-16 SL15216 (150719812) 31-JUL-16 SL15266 (150920349) 30-SEP-16 SL15267 (150920350) 30-SEP-16
- 510(k) numbers
- ["K902191"]
- PMA numbers
- not on file
- Product code
- OEQ
- Firm FEI
- 2648727
- Firm city
- Fajardo
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28