Recall Z-1213-2007 ยท FPA Set, Administration, Intravascular
Smiths Medical MD, Inc.
Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
| Date | Aug 30, 2007 (initiated Jun 18, 2007) |
| Status | Terminated |
| Reason | Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these Affected Cassettes have been used for delivering Flolan. |
| Root cause | Other |
| Action | All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD. |
| Quantity | 8555 boxes |
| Distribution | Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843772 | CADD-1 5100 AMBULATORY INFUSION PUMP Deltec Systems, Inc., Dec 6, 1984 |