Recall Z-1488-2016— Customed, Inc
Class II · Terminated
Class II FDA medical device recall by Customed, Inc, initiated 2016-01-07, terminated 2017-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Catalog Number: 900782 SKIN STAPLE REMOVER STERILE 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
- 2016-01-07
- Terminated
- 2017-05-03
- Firm location
- Fajardo, PR, United States
Product description
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE 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.