CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
FDA Recall Z-1767-2017 · Posted 2017-03-30
Advertisement
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-03-17
Date Terminated2019-07-03
Product Quantity38,415 (38145 US; 2268 OUS)
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.
Firm 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 [email protected]. For questions contact Stericycle at 844-265-7407. For further questions regarding this recall , please call (844) 265-7407.
Root Cause
Packaging process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement