Recall Z-1356-2020 ยท KCY Tourniquet, Pneumatic
Zimmer Surgical Inc
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 professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.
| Date | Jan 28, 2020 (initiated Jan 3, 2020) |
| Status | Terminated |
| Reason | When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders. |
| Root cause | Process control |
| Action | On 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 |
| Quantity | 58 |
| Distribution | Worldwide 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.