3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste sys
FDA device recall Z-0055-2013 · posted 2012-10-11 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
- Action taken
- ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com" for questions regarding this notice.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 60
- Distribution
- Nationwide distribution: Virginia only.
- Date initiated
- 2012-09-28
- Date posted
- 2012-10-11
- Date terminated
- 2013-02-19
- Location
- San Clemente, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIAC CATHERIZATION KIT (K914299) | Abbott Laboratories | 1992-06-03 |