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U.S. Department of Health and Human Services

Class 1 Device Recall Huber Needle

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 Class 1 Device Recall Huber Needlesee related information
Date Initiated by FirmMay 26, 2010
Date PostedJuly 02, 2010
Recall Status1 Terminated 3 on May 23, 2017
Recall NumberZ-1888-2010
Recall Event ID 55824
510(K)NumberK891919 
Product Classification needle, hypodermic, single - Product Code FMI
Product22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
Code Information Model number 10600218 Lot No 9B020M
Recalling Firm/
Manufacturer		 Multi-Med, Inc.
26 Victoria Ct
Keene NH 03431-4218
For Additional Information Contact
603-357-8733
Manufacturer Reason
for Recall		FDA sample determined the needles to be coring.
FDA Determined
Cause 2		Pending
ActionThe 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 astarkey@multimedinc.com.
Quantity in Commerce5169
DistributionWorldwide distribution
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FMI
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