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Recall Observatory FDA recall evidence

Device product

ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Z-2622-2015

July 10, 2015

Class II

Product summary

Firm
Customed, Inc
Event
Event 71721
Status
Terminated
Classification
Class II
Quantity
1128
Official record key
device-enforcement:Z-2622-2015

Official wording

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

Code information: Code:900210 Lots: 140915501 exp. 10/31/15 140915501 exp. 10/31/15 150116702 exp. 2/28/16 150116701 exp. 1/31/16 150116703 exp. 1/31/16 150116704 exp. 1/31/16 150116705 exp. 1/31/16 150116706 exp. 1/31/16 150217378 exp. 2/28/16 150217379 exp. 2/28/16 150217380 exp. 2/28/16 150217381 exp. 2/28/16 150217382 exp. 2/28/16 150317721 exp. 3/31/16 150317720 exp. 3/31/16 150318115 exp. 3/31/16 150318116 exp. 3/31/16 150318117 exp. 3/31/16 150318118 exp. 3/31/16 150418270 exp. 4/30/16 150418271 exp. 4/30/16 150418272 exp. 4/30/16 150418273 exp. 4/30/16

Distribution pattern: Distributed Only in Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate validation/qualification of sterilization processes
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    inadequate validation/qualification of sterilization