Recalls for Gauze/sponge, Internal, X-ray Detectable

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging

Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.

The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.

The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.

There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.

The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.

There is the potential for the RF ID tag to separate from the retaining pouch.

Complaints of leaking with question of sterility and risk of infection in eye.

Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.

Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

Potential compromise of product sterility due to breach of sterile barrier.

Potential lack of sterility assurance

This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Product packaging defective compromising sterility

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

Lint present on sterile Operating Room Towels.

Lint present on sterile Operating Room Towels.

Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change