The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Clorox Healthcare Holdings, LLC (dba HealthLink)
Class I - Dangerous
Due to lack of sterilization.
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
Surgical Instrument Service And Savings
Class I - Dangerous
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Class I - Dangerous
Incorrect blue/white suture was used.
Class I - Dangerous
GE Healthcare reported a potential safety issue due to temporary loss of X-Ray Imaging Modes during Collimator Auto-Calibration which affects Innova 3100 and Innova 4100 Systems.
Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
Surgical Instrument Service And Savings
Class I - Dangerous
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
The RPM of the Motor Handpiece may be less than 80,000 RPM.
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified
Surgical Instrument Service And Savings
Class I - Dangerous
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
The RPM of the Motor Handpiece may be less than 80,000 RPM.
Class I - Dangerous
BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet
Class I - Dangerous
This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
Surgical Instrument Service And Savings
Class I - Dangerous
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Class I - Dangerous
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Class I - Dangerous
Electrical power module installed on some in vitro diagnostic instruments does not meet industry standards as labeled.
Class I - Dangerous
Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.
Class I - Dangerous
It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Class I - Dangerous
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Class I - Dangerous
Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.