Date Initiated by Firm | May 11, 2011 |
Date Posted | June 28, 2011 |
Recall Status1 |
Terminated 3 on June 18, 2013 |
Recall Number | Z-2677-2011 |
Recall Event ID |
59005 |
510(K)Number | K092407 |
Product Classification |
Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
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Product | Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS.
The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain. |
Code Information |
Cat. # R01821 (10 pack) - Lot 028251, exp. 2011.06.13; Cat. #R01822 (100 pack) - Lot 028252, exp. 2011.06.13; 028883, exp. 2011.06.14; 028884, exp. 2011.06.14; and 031922, exp. 2011.06.21 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
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For Additional Information Contact | Earleen C. Parks 913-895-4185 |
Manufacturer Reason for Recall | The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA) |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 187/10-packs and 261/100-packs |
Distribution | Nationwide Distribution--including Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JSO
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