CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.
FDA device recall Z-1767-2017 · posted 2017-03-30 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- 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.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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
- Date initiated
- 2017-03-17
- Date posted
- 2017-03-30
- Date terminated
- 2019-07-03
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET (K040636) | Smiths Medical MD, Inc. | 2004-05-19 |