Recall Z-2652-2015— Customed, Inc
Class II · Terminated
Class II FDA medical device recall by Customed, Inc, initiated 2015-07-10, terminated 2017-04-12. FDA's recall record names no specific 510(k) clearance for this event. 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. .. Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile..
- Recalling firm
- Customed, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-10
- Terminated
- 2017-04-12
- Firm location
- Fajardo, PR, United States
Product description
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. .
Reason for recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.