Customed O.B. Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 125 O.B. 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 medical device) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 125 O.B. Packs (5/CS) that were distributed exclusively in Puerto Rico. These medical supplies are used by medical staff to perform surgical procedures and patient care tasks, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile. The affected products include code 900254 with lots 140915319 (exp. 3/31/17), 141015737 (exp. 10/31/15), and 141216441 (exp. 1/31/16).
The source text does not specify specific actions for consumers or medical facilities beyond the recall notice itself. Medical staff should verify their inventory against the listed lot numbers and expiration dates to ensure these specific units are not used.
The recalled product
- Product
- O.B. PACK 5/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
- Affected units
- 125
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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