CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265
FDA device recall Z-0775-2012 · posted 2012-01-17 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Smith Medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of CADD High Volume Administration Sets. EXPANDED: Smiths Medical became aware that an additional Product Reorder No. 21-738-01 and Lot No. 21X221 are also being recalled for receiving reports regarding occlusion/high pressure alarms with the use of these set
- Action taken
- Consignees were sent a Smiths Medical "Urgent Field Safety Notice" letter dated January 04, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Distributors and other users of these devices. The letter described the details on affected devices, Advise on Action to be Taken by the User and distributor and Transmission of this Urgent Field Safety Notice. Requested consignees to inspect their inventory and remove affected product and to complete and return the attached Confirmation Form. EXPANDED: The additional devices were distributed 12/14/2011 thru 1/27/2012. An Urgent Medical Device letter, dated 3/16/2012, was sent to customers beginning 3/16/2012. The letter identified the additional affected product, described what the issue is and asked that customers return all unused sets to Smiths Medical for credit or replacement. Also, the customer was asked to complete and return an Urgent Medical Device Recall Confirmation Form. If the customer is a distributor, they were asked to pass along the information to their customers.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 5,385 EXPANDED 16,125 devices
- Distribution
- Nationwide Distribution -- AZ, CA, FL, GA, IL, KS, LA, ME, MA, NC, OR, PA,SC, TX, VA, WA, and WI. EXPANDED to include AR, CO, IA, IN, MD, MI, MN, MO, NJ, OH, OK, TN, WV and Canada.
- Date initiated
- 2011-12-09
- Date posted
- 2012-01-17
- Date terminated
- 2012-11-06
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 (K991301) | Sims Deltec, Inc. | 1999-06-09 |