Surgical Instrument Service And Savings Recalls Compression Sleeves Due to Seal Failure
Surgical Instrument Service And Savings, Inc. is recalling 229 units of compression sleeves and garments 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, and the hazard involves a compromised sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Surgical Instrument Service And Savings, Inc. is recalling 229 units of various compression sleeves and garments, including Calf Garments, SCD Express Compression Sleeves, Thigh Garments, Vaso-Force Intermittent DVT Calf Garments, and VENAFLOW Calf Cuffs. The affected products are identified by specific reference numbers and lot numbers, including 122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, and 122715.
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 the sterile status of the device.
The affected products were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific lot numbers and reference numbers listed in the recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to the recall instructions.
The recalled product
- Product
- - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Expr
- Manufacturer
- Surgical Instrument Service And Savings, Inc.
- Affected units
- 229
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 (11)
- 122692
- 122982
- 122986
- 122984
- 122549
- 122985
- 122570
- 122546
- 122547
- 122574
- 122715.
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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