Instrument, Manual, Surgical, General Use

Medline Convenience kits used for various procedures:

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

ECONO STERILE medical procedure kits labeled as:

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

Trumpet, Needle Guide, Cat# TMS-200

The Ring on the Trump Needle Guide can detach when excessive pressure is applied.

Centurion STERILE #16 RUBBER BAND, Product Code EB16

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Epix Universal Clip Applier, REF: CA500, STERILEEO

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers:

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

Sterile Procedural Trays, labeled as the following: IM NAIL

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants

No expiration dates printed on the packaging

Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.

The devices may be packaged with the wrong reamer size.

Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd.

The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.