Surgical Suture Recall Due to Compromised Sterile Barrier Seal
Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The hazard involves a compromised sterile barrier, which is a significant quality issue, but the source text does not report any illnesses, injuries, or hospitalizations, and the defect is described as a potential for product to fall out of the pouch rather than an active contamination event.
Plain-English summary
Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266. The recall involves 2 units of the product intended for general and plastic surgery.
The recall was initiated because the seal that maintains a sterile barrier for the reprocessed medical devices became compromised. This defect may allow the product to fall out of the pouch, potentially compromising sterility.
The product was distributed nationwide. The source text does not specify the number of affected units beyond the quantity listed in the product description, nor does it report any illnesses or injuries. Consumers and healthcare providers should stop using the affected lot and contact the recalling firm for instructions.
The recalled product
- Product
- GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 2
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 (1)
- 123266
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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