6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
FREESTYLE LANCETS 28G 100CT Item Number:2975670
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22
Exact Medical Manufacturing
Class I - Dangerous
No 510k for the product to be used in a natural or surgical opening to the body
ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Cardinal Health
Class I - Dangerous
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Class I - Dangerous
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.
E3800 PC Units (spare parts)
Radiometer Medical ApS
Class I - Dangerous
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Class I - Dangerous
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Medtronic Perfusion Systems
Class I - Dangerous
Specific lots may have been manufactured with insufficient or incomplete welds.