Z-1888-2010
22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic...
Multi-Med, Inc. / initiated 2010-05-26 / Terminated
Multi-Med, Inc. began a recall of 22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports on . The reason FDA records is "FDA sample determined the needles to be coring". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1888-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Multi-Med, Inc.
- Product
- 22ga x 1" Straight Huber Needle This product is a small gauge needle intended for single use hypodermic access to implanted ports.
- Product code
- FMI Needle, Hypodermic, Single Lumen
- Reason for recall
- FDA sample determined the needles to be coring.
- FDA root cause
- Pending
- 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].
- Quantity in commerce
- 5169
- Distribution
- Worldwide distribution
- Product codes and lots
- Model number 10600218 Lot No 9B020M
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