Customed Hip and Knee Replacement Surgical Pack Recall for Sterilization Issues
Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential failure of sterilization in surgical packs, which poses a significant risk of infection or injury to patients.
Plain-English summary
Customed, Inc. is recalling 18 units of Catalog Number 9002614 Hip and Knee Replacement Surgical Packs. 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 lots are SL15212 (150719962), SL15274 (150920990), and SL15274 (150920989).
The products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 9002614 HIP AND KNEE REPLACEMENT 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
- 18
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.
See all 100 products in this recall →Related recalls
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