Customed Retina Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 21 units of Retina Pack 7/CS 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 the hazard is theoretical due to inadequate sterilization validation, with no reported injuries or illnesses in the source text.
Plain-English summary
Customed, Inc. is recalling 21 units of Retina Pack 7/CS. These medical packs are used by 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 sterilization processes, as well as package integrity issues for products released as sterile.
The affected products were distributed only in Puerto Rico. The recall covers specific lots with expiration dates ranging from December 31, 2015, to August 30, 2018. The agency classification for this recall is Class II.
Healthcare facilities and consumers should stop using the affected Retina Packs and contact the recalling firm or their supplier for instructions on return or replacement.
The recalled product
- Product
- RETINA PACK 7/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
- 21
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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