Nov 17, 2022 FDA device enforcement
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of AR, MD, WA, WI.
Official source for Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case Nov 17, 2022 FDA device enforcement
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Class II Reported ongoing
Distribution: US Nationwide distribution in the states of AR, MD, WA, WI.
Official source for Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for ANCILLARY PACK-LF. Sterile Procedural Tray. Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for TRACH PACK. Sterile Procedural Tray. Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for LOCAL PACK. Sterile Procedural Tray. Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for FEMORAL ARTERY PACK-LF. Sterile Procedural Tray Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c.... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTION CDS-3 b. RESIDENT DER... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PAC... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c.... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. RHINOPLASTY PACK b. OSC OTOLOGY PACK-LF c.... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. LAPAROTOMY CDS-LF b. LAPAROSCOPY CDS-LF c.... Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO Nov 17, 2022 FDA device enforcement
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Class II Reported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Official source for Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CD...