22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
FDA Recall Z-1888-2010 · Posted 2010-07-02
Recalling FirmMulti-Med, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2010-05-26
Date Terminated2017-05-23
Product Quantity5169
Reason for Recall
FDA sample determined the needles to be coring.
Firm Action
The firm, Multi Med, Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 26, 2010 to their sole consignee Navilyst Medical, Inc., via email and overnight courier with signature notification. The letter describes the product, problem and action to be taken by customer. The customers was instructed to immediately examine their inventory and quarantine product subject to recall, if the product was distributed to others customers, identify and notify them at once and include recall notification letter,. Recall has been initiated due to FDAs sample analysis that these needles may core implanted port septums.
If you have any questions, call me, Sue Starkey, at 603-357-8733 or via email at [email protected].
Root Cause
Pending
Distribution Pattern
Worldwide distribution
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.