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Surgical Instruments

NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

ICU Medical

Class I - Dangerous

Due to the incorrect filter assembly.

Dec 2, 2020 Surgical Instruments Nationwide View Details →

CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Aomori Olympus Co.

Class I - Dangerous

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Jan 4, 2021 Surgical Instruments Nationwide View Details →

Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12

Ethicon

Class I - Dangerous

Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach

Jan 4, 2021 Surgical Instruments Nationwide View Details →

BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348

Becton Dickinson & Company

Class I - Dangerous

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

Dec 9, 2020 Surgical Instruments View Details →

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067

Stryker Sustainability Solutions

Class I - Dangerous

A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

Mar 27, 2020 Surgical Instruments View Details →

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