🏥 Medical Devices • 7,015 recalls
Bard Peripheral Vascular
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Bard Peripheral Vascular
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Bard Peripheral Vascular
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
products may be missing a one-way valve on the fluid patient port.
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Products have been packaged with the wrong Trocar length type.
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
DeRoyal Industries
Non-sterile product was packaged inside a case that was labeled as sterile.
Beijing Syntech Laser Co.
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Carefusion 2200
The integrity of the sterile packaging is potentially compromised.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.