Recalls That Should Be on Your Radar— Week of August 4, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Centurion Medical Products Issues Recall for Kit Containing Sheridan Endotracheal Tubes Due to Potential Malfunction

Teleflex informed Centurion of its recall for select Sheridan® Endotracheal Tubes and Connectors, as Centurion includes the recalled product in their convenience kit. Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient from the breathing circuit, which may result in insufficient oxygenation, decrease in vital signs, or death.

Four deaths and 18 injuries have been reported to Teleflex in association with disconnection. However, Centurion has not received any complaints or reports of deaths or injuries related to the Teleflex recalled product.

The use of affected product may cause serious adverse health consequences, including death.

Read about the endotracheal tube recall.

AIDEN Issues Recall for Filter Tips Due to Potential to Leak

Due to a manufacturing malfunction resulting in defective filter-tips having internal abrasions from a bent manufacturing pin, the affected QIAGEN filter-tips have the potential to leak, which may result in delayed or inaccurate results, including false positive results, false negative results, or incorrect quantification. Customers have reported splashes on the QIAsymphony instrument, liquid in the tip guard, dripping/leaking tips, failed test signals, empty wells indicative of volume loss, and incorrect test results with use of the defective tips.

Severe adverse health consequences, including death, could potentially occur if incorrect results are not detected. The risks are dependent on the specific test being run and how important the test result is for clinical diagnosis. For example, false positive results using the JAK2 assay could provide support for the diagnosis of a myeloproliferative neoplasm, potentially culminating in stem cell transplantation, which has a risk of long-term complications including increased mortality and secondary malignancy.

The company received three complaints from U.S. customers. There were no injuries or deaths reported.

Read more about the filter tip recall.

Abbott (Formerly St. Jude Medical Inc.) Issues Recall for Ellipse Implantable Cardioverter Defibrillators Due to Exposed Wires

Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor. The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices. Of the devices recalled in the US, 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaints or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.

Read about the defibrillator recall.

Top Taste Food Warehouse Issues Recall for Meat and Poultry Products Produced Without Benefit of Inspection

Top Taste Food Warehouse, a Brooklyn, N.Y. establishment, is recalling an undetermined amount of pork and chicken dumpling product because they were produced, packed, and distributed without the benefit of USDA inspection and used the mark of inspection without authorization, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen pork with vegetable dumpling and the chicken with vegetable dumpling items were produced July 30, 2018 through July 31, 2019.

The products subject to recall bear establishment number “EST. 19856” inside the USDA mark of inspection. These items were shipped to wholesalers in New York.

The problem was discovered on July 31, 2019 while FSIS was conducting surveillance activity.

Read about the meat and poultry recall.

Ridge Properties LLC Issues Recall of PRE-TAT Cream and Gel Products due to Microbiological Contamination and Superpotency

Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine.

The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application and tattooing is known to have infectious complications. Additionally, use of lidocaine greater than the label claim may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced. To date, the company has not received any reports of adverse events related to this recall.

PRE-TAT is marketed as a numbing agent/topical anesthetic used prior to tattoo application. Soothing Sore Relief is marketed for soothing relief of pain and/or itch associated with hemorrhoids and bedsores. Superior pain and itch relief is marketed as a numbing agent/topical anesthetic. Lots & expiration dates are listed on a gold colored expiration sticker on the back of the products. Products were distributed nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com.

Read about the topical anesthetic recall.