Recall Z-2759-2017 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD Inc.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
| Date | Dec 9, 2016 |
| Status | Terminated |
| Reason | The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada. |
| Root cause | Unknown/Undetermined by firm |
| Action | Customers were sent an Urgent Medical Device Safety Notice, dated 12/9/2016. The letter identified affected product and stated the reason for recall. The letter also provided a list of devices that each consignee ordered, along with the date of manufacture and associated expiration date. Customers were asked to locate devices and compare to the list and determine if affected devices are within expiration date. If the device is expired customers are to dispose of them per their procedures for dealing with expired product. If devices are not expired, they may continue to use them through th |
| Quantity | 641,070 units |
| Distribution | Canada only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933390 | REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG Pharmacia Deltec, Inc., Feb 9, 1994 |