remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube o
FDA device recall Z-1139-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Pouch may be inadequately heat sealed compromising sterility
- Action taken
- An IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated January 18, 2010, was sent to customers via regular mail. The notice described the product, problem, and action to be taken by the customers. The customers are requested to: review their inventory for the indicated product, discard all remaining units of the product lot, complete the "Product Inventory Checklist" enclosed to report the amount of product they wanted replaced or credited, and return by February 1, 2010 regardless if they have affected product and/or have verbally contacted the firm. If you have any inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 (USA) or 913-888-0930 (International).
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JSM
- Quantity affected
- 154/10-unit packages
- Distribution
- Nationwide distribution: MI, MA, WV, CO, ME, FL, NJ, MD, WA, AZ, VA, CA, KS, IL, MO, AL, TN
- Date initiated
- 2010-01-18
- Date posted
- 2010-03-15
- Date terminated
- 2012-04-25
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A.C.T. II (K965152) | Remel Co. | 1997-01-22 |