Customed sterile medical products recalled due to sterilization validation issues
Customed, Inc. is recalling sterile medical products used for surgical and patient care procedures in Puerto Rico due to inadequate sterilization validation 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 and involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to inadequate sterilization validation, with no reported illnesses or injuries in the source text.
Plain-English summary
Customed, Inc. is recalling specific lots of sterile medical products used by medical staff for surgical procedures and patient care, such as wound healing and suture removals. 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 specific lots involved are 150317643 and 150317644, both with an expiration date of March 31, 2016. The agency classification for this recall is Class II.
Consumers and medical facilities should stop using these specific lots of products and contact the recalling firm or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- (1) (2) 10/CS CUSTOMED 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
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Code:9002482 Lots: 150317643 exp. 3/31/16 150317644 exp. 3/31/16
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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