Customed Shoulder Arthroscopy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs 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 risk-of-harm product (sterile surgical pack) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs (Code 9002719) distributed in Puerto Rico. 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 140915486 (exp. 4/30/16), 150116570 (exp. 1/31/16), 150116569 (exp. 1/31/16), and 150116568 (exp. 3/31/16). 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 source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- SHOULDER ARTHROSCOPY PACK 2/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
- 10
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.
See all 170 products in this recall →Related recalls
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