Recall Z-1627-2013— Surgical Instrument Service And Savings, Inc.
Class II · Terminated
Class II FDA medical device recall by Surgical Instrument Service And Savings, Inc., initiated 2013-05-03, terminated 2013-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.. Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch..
- Recalling firm
- Surgical Instrument Service And Savings, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-03
- Terminated
- 2013-07-11
- Firm location
- Redmond, OR, United States
Product description
-Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
Reason for recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.