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U.S. Department of Health and Human Services

Class 2 Device Recall ourniquet Cuff 30" (Blue), LuerLock Dual Port, single Bladder

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 Class 2 Device Recall ourniquet Cuff 30" (Blue), LuerLock Dual Port, single Bladdersee related information
Date Initiated by FirmMay 31, 2024
Date PostedJuly 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2405-2024
Recall Event ID 94824
Product Classification Tourniquet, pneumatic - Product Code KCY
ProductREF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Code Information Lot: 0000564862/ UDI: 00885825015411
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information ContactAshley Lower
888-888-3433
Manufacturer Reason
for Recall		Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
FDA Determined
Cause 2		Employee error
ActionOn June 14, Stryker Sustainability Solutions issued a "Urgent: Medical Device Recall" Notification to affected consignees via mail. Stryker ask consignees to take the following actions: 1) Please check your inventory for the devices from the affected lots and remove them from their point of use. a. Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form to Email: SSSPFA@stryker.com This form must be completed and returned to Stryker even if no affected product is found. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned.
Quantity in Commerce90 units
DistributionUS Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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