Customed Fan Fold Sheets Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,920 fan fold sheets 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 and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 1,920 units of Catalog Number 900633 Fan Fold Sheets (44 x 58). These products are used by medical staff for surgical procedures and patient care tasks such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. The affected lots are SL15203 (150719894) and SL15208 (150518835). The products were distributed only in Puerto Rico.
The U.S. Food and Drug Administration has classified this recall as Class II. No specific instructions for consumers are provided in the source text, but the products should not be used until further notice.
The recalled product
- Product
- Catalog Number: 900633 FAN FOLD SHEET 44 X 58 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
- 1,920
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)
- LOTS: SL15203 (150719894) 31-JUL-16 SL15208 (150518835) 31-MAY-16
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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