Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744
FDA Recall Z-0051-2007 · Posted 2006-10-21
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Recalling FirmKendall a Division of Tyco Healthcare Group LP
Recall StatusTerminated
Product CodeFMF
Date Initiated2006-09-11
Date Terminated2009-09-11
Product Quantity130,000
Reason for Recall
Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
Firm Action
A recall letter was mailed 9/12/2006 to the 44 customers who purchased this product from Tyco Healthcare. The firm requested that their distributors notify their customers, and coordinate recovery of the product. The recall mailing included a form that was to be faxed back to Tyco Healthcare. A postage paid return envelope was also included if the customer does not have access to a fax machine.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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