Recall Z-2289-2016
LeMaitre Vascular, Inc. · initiated June 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Codes / lots: Lot Numbers: ANR1067¿ ANR1073¿
Reason for recall
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: CSUS@LEMAITRE.COM or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.
Details
- Recall number
- Z-2289-2016
- Initiated
- June 22, 2016
- Terminated
- April 8, 2021
- Product code
- FZP – Clip, Implantable
- Quantity
- 20 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- LeMaitre Vascular, Inc., Burlington, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2283-2016 Class II | Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |
| Z-2284-2016 Class II | AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |
| Z-2285-2016 Class II | Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |
| Z-2286-2016 Class II | AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |
| Z-2287-2016 Class II | AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |
| Z-2288-2016 Class II | AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… | 06/22/2016Terminated |