Customed Basic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 432 Basic 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling 432 units of the Basic Pack, a medical product used by staff for surgical procedures and patient care tasks such as wound healing and suture removal. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile.
The affected products were distributed only in Puerto Rico. The recall involves specific lot numbers with expiration dates ranging from November 2015 to June 2016. No illnesses or injuries have been reported in the source text.
Medical facilities and consumers should stop using these products and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- BASIC PACK 8/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
- 432
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.
See all 170 products in this recall →Related recalls
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