Intraosseous Products - recalled due to limited or non-functioning intraosseous access, USA

1 year ago •source www.fda.gov

Recall notice

United States

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in the following:

- Difficulty separating the stylet from the intraosseous needle, where increased force required to remove the stylet from the intraosseous needle results in inadvertent removal of the entire needle assembly during placement or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access.

- Needle safety mechanism on the stylet not deploying post placement of the intraosseous needle and removal of the stylet from the needle.

- Metal discs intended to connect the needle assembly to the magnet in the powered driver sticking unexpectedly to the magnet, rendering the driver unable to be used.

These issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries.

Impacted products include:

- Needle Kit for Powered Driver 15mm x 15Ga. Catalog No.: D015151NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 15mm x 15Ga. Catalog No.: D015151MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 25mm x 15Ga. Catalog No.: D015251NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 25mm x 15Ga. Catalog No.: D015251MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 35mm x 15Ga. Catalog No.: D015351NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 35mm x 15Ga. Catalog No.: D015351MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 45mm x 15Ga. Catalog No.: D015451NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 45mm x 15Ga. Catalog No.: D015451MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 55mm x 15Ga. Catalog No.: D015551NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 55mm x 15Ga. Catalog No.: D015551MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Intraosseous Powered Driver (drill). Catalog No.: D001001. UDI: 801741163579. Lot No.: All. Expiration Date All. Product Package Size: 1 device per package.

Customers should immediately review their inventory for the catalog and lot numbers listed above. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal. The use of affected intraosseous powered drivers should be paused until a BD representative provides instruction that it is safe for use. There are no replacement products currently.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: BD
Brand name: BDTM
Product recalled: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers
Reason of the recall: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries
FDA Recall date: June 22, 2022

Source: www.fda.gov

#medicaldevices #us #lays

303

Recent Interesting Reports

Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander, USA

1 week ago •source www.fda.gov

Recall notice

Global Mix, Inc. of New York, is recalling tejocote products to include the following brands: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra. The recalled products are labeled as tejocote root but are toxic yellow oleander. The recalled products were distributed in the following states: AL, AK, … See More
CA, CO, CT, DE, FL, GA, HI, ID, IL, IA, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NM, NC, NY, NJ, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, and WY through website. The recalled products were also sold via the below websites via courier direct delivery and mail order. Etsy, amazon, eva-nutrition, tejocotemexican, niwali, scienceofalpha. The recalling firm has not received any reported of illness.

Recalled Products include the following bearing below information. Product codes and expiration dates can be found on the bottom of the packaging.

Product Name: Eva Nutrition MexicanTejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Science of Alpha Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: NWL Nutra Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025
Product Name: Niwali Mexican Tejocote root, Serial No: 181121U, Mfg Date: 08/01/2023, Expiry Date: 06/2025

Per the safety alert update on 3/12/24, "The FDA continues to receive adverse event reports related to the products identified in this Safety Alert."

The recall was the result of a routine sampling program by the company which revealed that the finished products contained the yellow oleander. The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem. Further the company is conducting comprehensive quality control and monitoring process.

Customers who have purchased these products should stop using them immediately and return them to the point of purchase for a full refund.

Ingestion of yellow oleander can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia, and more.

If you are experiencing symptoms after eating this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Global Mix, Inc.
Brand name: Eva Nutrition, Science of Alpha, Niwali, NWL Nutra
Product recalled: Tejocote Dietary Supplements
Reason of the recall: Product contains toxic yellow oleander.
FDA Recall date: April 10, 2024

Source: www.fda.gov
See Less

#recall #us

Tejocote Dietary Supplements - recalled because it contains toxic yellow oleander photo #1
303
Y

Not the same as advertised, New Orleans, LA, USA

3 days ago •reported by user-ybpyc327

I order two of the nano tech bullet proof vest, when it arrived the material was a thin allistic material and not seeing hours this material could stop any for arm nor knife stabbing.. I want the correct item or my money back!! But it came from Heathers Morty’s out of Union City, New Jersey 07087

#scam #onlineshopping #delivery #onlinescam #neworleans #louisiana #us

Not the same as advertised photo #1
401

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