| Class 2 Device Recall Color Cuff Disposable Tourniquet Cuff | |
Date Initiated by Firm | November 06, 2019 |
Create Date | December 02, 2019 |
Recall Status1 |
Terminated 3 on November 19, 2021 |
Recall Number | Z-0592-2020 |
Recall Event ID |
84316 |
Product Classification |
Tourniquet, pneumatic - Product Code KCY
|
Product | Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field. |
Code Information |
GTIN: 37613154599258, Lot Numbers 60180348, 60180373 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
|
Manufacturer Reason for Recall | There is a potential for the cuff to leak air leading to a loss of vascular occlusion. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Urgent Medical Device Recall Notification letters dated 11/6/19 were sent to customers.
Actions to be taken:
1. Immediately review this Recall Notification and the Business Reply Form.
2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and
discontinue use of any Color Cuff Disposable Tourniquet Cuffs identified in this Notification.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how
many affected items are currently in your inventory. Please complete and return the BRF even if you dont
have any affected product on hand. Return the completed BRF via fax (8665212762) or email to
kara.spath@stryker.com.
Note: Your signature on the BRF indicates that you received and understand this Notification and have
followed the instructions in the Notification.
4. If you have further distributed this product, please forward copies of this Notification and the BRF to all
affected locations, for each location to complete and return. Even if you have distributed all product to
another location, please complete a BRF and indicate each location that received product.
5. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be
provided which should be used to return recalled product. Upon receipt of the recalled product, a credit
will be applied to your account. |
Quantity in Commerce | 16,380 total |
Distribution | Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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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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