Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling obstetrical surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile surgical packs) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling obstetrical surgical packs (Code 9002940) that were distributed only in Puerto Rico. These products are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots include 140915333, 141116022, 150418387, 150418388, 150418497, 150418496, 150518909, 150518910, 150619184, and 150619183, with expiration dates ranging from December 31, 2015, to February 28, 2019.
The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these products. Medical facilities and consumers in Puerto Rico should check their inventory for these specific lot numbers and contact the recalling firm for further instructions.
The recalled product
- Product
- OBSTETRICAL SURGICAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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