Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the labe
FDA device recall Z-2677-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
- Action taken
- Remel, Inc. sent an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letter, dated May 10, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory and discard all remaining product lots. Additionally, customers are to complete the Product Inventory Checklist and indicate whether or not they desire replacement of the product or credit. A self-addressed , stamped envelope was enclosed in the letter to use to return the checklist. Questions can be answered by contacting the Technical Services Department at 800-255-6730 or 913-888-0939.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 187/10-packs and 261/100-packs
- Distribution
- Nationwide Distribution--including Puerto Rico.
- Date initiated
- 2011-05-11
- Date posted
- 2011-06-28
- Date terminated
- 2013-06-18
- 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 |
|---|---|---|
| REMEL SPECTRA MRSA (K092407) | Remel, Inc. | 2010-10-08 |