Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C 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 surgical packs) 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 536 units of Arthroscopy Surgical Pack 4/C. These sterile surgical packs 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 recall includes specific lots with expiration dates ranging from December 31, 2015, to June 30, 2016. The FDA has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected products immediately. Users should contact Customed, Inc. for further instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- ARTHROSCOPY SURGICAL PACK 4/C 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
- 536
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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