Customed, Inc: Medical Device Recall in 2016 - (Recall #: Z-1489-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 7, 2016

Date Posted: April 20, 2016

Recall Number: Z-1489-2016

Event ID: 72992

Reason for Recall:

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Status: Terminated

Product Quantity: 16

Code Information:

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

Distribution Pattern:

Distributed only in Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated