Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 360 Ophthalmic 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 the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 360 units of Ophthalmic Packs (Code 9001933) that were distributed exclusively in Puerto Rico. These sterile medical device packs are used by medical staff to perform surgical procedures and patient care tasks, 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 include 140814975, 140513118, 141216436, 150116975, 150116781, 150518667, and 150619226, with expiration dates ranging from January 31, 2016, to June 30, 2017.
Healthcare facilities and medical staff in Puerto Rico should stop using these specific lots immediately. The source text does not report any illnesses or injuries associated with this recall.
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
- 360
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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