Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak
Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm to patients during surgery, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Surgical Inc is recalling 58 units of Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200. The recall is due to a defect where a leak between the bladders could cause both bladders to inflate or deflate when only one is intended to be used.
The affected product is identified by Lot 27968701 and UDI (01)00889024377547 (17)230812(10)27968701. These tourniquets are intended to be used by qualified medical professionals to exert pressure on arterial blood flow in a limb to produce a bloodless operating field.
The product was distributed worldwide, including nationwide in the United States in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV, as well as in the Netherlands. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical…
- Manufacturer
- Zimmer Surgical Inc
- Hazard
- Affected units
- 58
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)
- Lot 27968701
Distribution
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