Customed Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 540 surgical 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 potential loss of sterility in surgical packs, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 540 units of Surgical Packs (20/CS) 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.
These surgical packs are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The affected lots include code 9002224 with specific lot numbers and expiration dates ranging from December 31, 2015, to June 30, 2016.
Medical facilities and consumers who have these specific surgical packs should stop using them and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- SURGICAL PACK 20/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
- 540
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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