Surgical Instruments

Ethicon is recalling EVARREST Fibrin Sealant Patch because the characters "0-bad" were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).

Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.

It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction

Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.

BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the attachment end of the motor. There is a negligible possibility that the orange grease may leak from the attachment end of the motor and contaminate the surgical wound resulting in soft tissue inflammation.

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.

Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.