Customed Premium Arthroscopy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 85 Premium Arthroscopy 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 sterile medical device with a risk of infection due to inadequate sterilization validation, which fits the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 85 units of the Premium Arthroscopy Pack (Catalog Number 9001298). These sterile medical device packs are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation. The specific lot affected is SL15195-02 (150719829), with a date code of 31-JUL-16.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile. This means the manufacturer could not guarantee that the products were effectively sterilized or that the packaging maintained its integrity to keep the contents sterile.
The affected products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific packs should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 9001298 PREMIUM ARTHROSCOPY 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
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOTS: SL15195-02 (150719829) 31-JUL-16
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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