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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC

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 Class 2 Device Recall Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLCsee related information
Date Initiated by FirmJanuary 03, 2020
Date PostedJanuary 28, 2020
Recall Status1 Terminated 3 on October 30, 2020
Recall NumberZ-1356-2020
Recall Event ID 84752
Product Classification Tourniquet, pneumatic - Product Code KCY
ProductZimmer 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 professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
Code Information Lot 27968701
Recalling Firm/
Manufacturer		 Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall		When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
FDA Determined
Cause 2		Process control
ActionOn January 3, 2020, the recalling firm distributed recall notices to affected customers via email and FedEx. Customers were instructed to ensure that affected personnel are aware of the contents, and assist the Zimmer Biomet sales representative to locate, quarantine, and return all affected product. If you have questions or concerns regarding this recall, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce58
DistributionWorldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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