Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk of harm from potential sterility failure in a medical device, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 525 units of Cesarean Packs (Code 900660) distributed exclusively 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 141015724 (exp. 10/31/15), 150116818 (exp. 1/31/16), 150217433 (exp. 1/31/16), 150217434 (exp. 1/31/16), 150318123 (exp. 3/31/16), 150418262 (exp. 4/30/16), and 150418263 (exp. 4/30/16). These products are used by medical staff for surgical procedures and patient care, including wound healing, suture removals, and wound irrigation.
Medical facilities and consumers in Puerto Rico should stop using these specific lots and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- CESAREAN 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
- 525
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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