PlainRecalls
FDA Devices Moderate Class II Ongoing

Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.

Reported: August 7, 2024 Initiated: June 27, 2024 #Z-2451-2024

Product Description

Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.

Reason for Recall

Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

Details

Units Affected
70,890 units total
Distribution
Domestic: Nationwide Distribution. International: Pending
Location
Marlborough, MA

Frequently Asked Questions

What product was recalled?
Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures during open surgical procedures.. Recalled by Boston Scientific Corporation. Units affected: 70,890 units total.
Why was this product recalled?
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 7, 2024. Severity: Moderate. Recall number: Z-2451-2024.