Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 88815
FDA device recall Z-0051-2007 · posted 2006-10-21 · Terminated
Recall details
- Recalling firm
- Kendall a Division of Tyco Healthcare Group LP
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 130,000
- Distribution
- Nationwide
- Date initiated
- 2006-09-11
- Date posted
- 2006-10-21
- Date terminated
- 2009-09-11
- Location
- Argyle, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES (K852544) | Sherwood Medical Co. | 1985-07-23 |