22ga x 1" Right Angle Huber Needle This product is a small gauge needle intended for single use hypodermic access to imp
FDA device recall Z-1889-2010 · posted 2010-07-02 · Terminated
Recall details
- Recalling firm
- Multi-Med, Inc.
- Reason for recall
- FDA sample determined the needles to be coring.
- Action taken
- 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 astarkey@multimedinc.com.
- Root cause
- Pending
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 5,000
- Distribution
- Worldwide distribution
- Date initiated
- 2010-05-26
- Date posted
- 2010-07-02
- Date terminated
- 2017-05-23
- Location
- Keene, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET (K891919) | Multi-Med, Inc. | 1989-05-05 |