Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 546 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
What this means for you
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 injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling 546 units of Ophthalmic Packs (6/CS) under recall number Z-2612-2015. These products are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The affected units were distributed only in Puerto Rico.
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 source text does not report any specific illnesses, injuries, or deaths associated with these products.
Healthcare facilities and consumers who possess these specific lots should stop using the products and contact the manufacturer or the FDA for further instructions. The affected lots include 141015756, 141216419, 150116978, 150317700, 150317701, 150317702, 150518592, 150518593, and 150518594.
The recalled product
- Product
- OPHTHALMIC PACK 6/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
- Category
- Medical Device — Surgical Packs
- Affected units
- 546
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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