FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0051-2007
- Recalling firm
- Kendall a Division of Tyco Healthcare Group LP
- Product
- Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc- 27x1-1/4 A) Product # 8881513744
- Status
- Terminated
- Initiated
- 2006-09-11
- Posted
- 2006-10-21
- Terminated
- 2009-09-11
- 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
- Lot, serial or model codes
- Lot Numbers: 611406 and 611407
- 510(k) numbers
- K852544
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1317749
- Firm city
- Argyle
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28