Recall Z-0069-2019 ยท FMG Stopcock, I.V. Set
ICU Medical, Inc.
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
| Date | Aug 20, 2018 |
| Status | Completed |
| Reason | Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included. |
| Root cause | Device Design |
| Action | On 08/20/18, the firm, icumedical, mailed "URGENT MEDICAL DEVICE RECALL" l notices to consignees. The notice described the product, problem and actions to be taken. If product has been further distributed, the firm requested consignees to notify users. Customers were advised to return affected product only if the blood filter is needed. Customers needing response forms and/or return labels were advised to call 1-800-479-0551. For further inquiries call: 1-866-829-9025. |
| Quantity | 2361 Units |
| Distribution | U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964435 | PRIMARY IV SET Icu Medical, Inc., Apr 2, 1997 |