Recall Z-1767-2017 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD Inc.
CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
| Date | Mar 30, 2017 (initiated Mar 17, 2017) |
| Status | Terminated |
| Reason | Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns. |
| Root cause | Packaging process control |
| Action | Smiths Medical sent an "Urgent Medical Device Field Safety Notice" dated March 13, 2017. The letter was addressed to "Risk Manager". It provided a list of the Affected devices, Risk to Health, Instructions to Distributors & Customers. Advised consignees to notify their customers. There is no need to return the devices to Smiths Medical. Requested consignees to complete the Urgent Medical Device Field Safety Notice (FSN) Response Form and return to smithsmedical3947@stericycle.com. For questions contact Stericycle at 844-265-7407. For further questions regarding this recall , please call ( |
| Quantity | 38,415 (38145 US; 2268 OUS) |
| Distribution | US:AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY. OUS: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET Smiths Medical MD, Inc., May 19, 2004 |