Customed Extremity Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 136 Extremity Surgical Packs 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 a risk-of-harm product (sterile surgical pack) where the failure of sterilization validation implies a potential for infection, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Customed, Inc. is recalling 136 units of the Extremity Surgical Pack (Catalog Number 9002615). These sterile medical device packs are used by medical staff to perform surgical procedures and patient care procedures, including 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 the products released for distribution as sterile. The affected lots are SL15181, SL15184, SL15274, and SL15275, with expiration dates ranging from June 30, 2016, to September 30, 2016.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these specific lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 136
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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