Customed Lithotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 370 units of Lithotomy 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 (potential lack of sterility) and no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 370 units of Lithotomy Packs (Code 9002167) that were distributed only in Puerto Rico. 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 141015702 (exp. 10/31/15), 141216298 (exp. 12/31/15), 150116521 (exp. 12/31/15), 150116996 (exp. 2/28/16), 150418348 (exp. 6/30/16), 150518685 (exp. 6/30/16), and 150418347 (exp. 6/30/16). 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 source text does not specify specific actions for consumers or medical staff, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- LITHOTOMY PACK 10/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
- Affected units
- 370
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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