Recall Z-0051-2007 ยท FMF Syringe, Piston
Kendall a Division of Tyco Healthcare Group LP
Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744
| Date | Oct 21, 2006 (initiated Sep 11, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 130,000 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852544 | MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES Sherwood Medical Co., Jul 23, 1985 |