Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 168 ophthalmic surgical 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 surgical packs) where inadequate sterilization validation poses a theoretical risk of infection, but no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 168 units of Ophthalmic Surgical Packs, Catalog Number 9001933. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The specific lots involved are SL15176, SL15231, SL15233, SL15240, and SL15259, with expiration dates ranging from June 30, 2016, to September 30, 2016. The source text does not report any illnesses or injuries associated with these products.
Healthcare facilities and consumers should stop using these specific lots of ophthalmic surgical packs. Users should contact Customed, Inc. for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Catalog Number: 9001933 OPHTALMIC 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
- 168
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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