Customed Shoulder Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of 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 involves a medical device with a risk of harm due to potential sterility failure, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 413 units of Shoulder Packs (Code 9002616) 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 due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots have expiration dates ranging from October 31, 2015, to June 30, 2016.
Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- SHOULDER PACK 6/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
- 413
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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