Cannula, Surgical, General & Plastic Surgery

ECONO STERILE medical procedure kits labeled as:

Reports of various packaging issues that may result in a breach of the sterile barrier.

Various trauma and sports medicine instruments and implants.

Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Genicon 5mm Pyramidal Trocar, Sterile, Genion 6869 Stapoint Court, Suite 114 Winter Park, FL U.S.A. 32792, Rx Only. Catalog Numbers: 100-005-001 & 100-005-002.

The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar.

ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905.

Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection

25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

The wrong product in the box.

25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End

The wrong product in the box.

MicroAire PAL Cannula

MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.

Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and as

Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg MR Introducer; a device used to aid the insertio

single use devices labeled as sterile may not have been adequately sterilized

Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held

There was incorrect raw material used in the production of the identified lot.