Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential loss of sterility due to a packaging seal defect, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires. The affected products include the Scorpion Needle (Blue, Ref. AR-13990N, Lot 123263), SureFire Scorpion Needle (Purple, Ref. AR-13991N, Lots 123263 and 122279), and Suture Passing Wire (Ref. AR-1255-18, Lot 123190). These are manual surgical instruments for general use.
The recall was initiated because the seal that maintains a sterile barrier for these reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility. The agency classified this as a Class II recall.
The products were distributed nationwide. A total of 6 units are involved in this recall. Users should check their inventory for the specific reference numbers and lot numbers listed above and stop using the affected items.
The recalled product
- 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.
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 6
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 (3)
- 123263
- 122279
- 123190.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Surgical Instrument Service And Savings, 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.
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