CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
This recall has been terminated (originally issued March 30, 2017).
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- March 17, 2017
- Posted
- March 30, 2017
- Terminated
- July 3, 2019
- Recall Number
- Z-1767-2017
- Quantity
- 38,415 (38145 US; 2268 OUS)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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
Lot / Code Info
46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
Root Cause
Packaging process control
Action Taken
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 (844) 265-7407.