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U.S. Department of Health and Human Services

Class 2 Device Recall CADD Administration Set, 21733924, Rx Only, Sterile EO.

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  Class 2 Device Recall CADD Administration Set, 21733924, Rx Only, Sterile EO. see related information
Date Initiated by Firm March 17, 2017
Date Posted March 30, 2017
Recall Status1 Terminated 3 on July 03, 2019
Recall Number Z-1767-2017
Recall Event ID 76749
510(K)Number K040636  
Product Classification Set, administration, intravascular - Product Code FPA
Product CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Code Information 46X817, 46X829, 46X899, 46X828, 46X896, 46X990, 46X831, 46X897, 46X1001.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Stericycle
844-265-7407
Manufacturer 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.
FDA Determined
Cause 2		 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 (844) 265-7407.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = SMITHS MEDICAL MD, INC.
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