Product Recall
Information

Coloplast Recall

Coloplast, the manufacturer of various urological, ostomy and medical supplies, has issued an urgent medical device recall notice.

This recall is related to a potential sterility issue found during testing at their facility. The defect in the packaging is not easily visible to users, but the risk of clinical impact is considered low, per the manufacturer. The affected products were first shipped on April 20, 2020.

Per manufacturer recommendations, please discontinue use of any products matching the affected item and lot number listed here.

Should you possess a recalled product, please contact us to request a no-charge replacement. If your specific product is unavailable, an available and comparable alternative will be shipped to you. Please note, upcoming supply orders will not include the specific lot numbers included in this recall.

If you have questions about the recalled products, please contact Coloplast directly at (855) 745-8549

• Aveanna Patient Communication

Applied Medical Technology (AMT) Recalls Specific Lot of AMT Mini Enteral Extension Sets.

Applied Medical Technology has issued an urgent medical device recall notice regarding a specific lot of their AMT Mini Enteral Extension Set. This notice has been issued because the extension sets subject to this recall have Enfit connections although they should have non-Enfit connections. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Per manufacturer recommendations, please discontinue use of any products matching the affected item and lot number listed below.

Item Number	Description	Lot Number	Expiration Date
6-1222	CONNECTOR, RT ANGL W/Y-PORT ADPTR 12"	240424-628	4/1/2027

Affected product first shipped from the manufacturer on September 12, 2024. Item Number 6-1222 is a legacy (non-Enfit) extension set; however, this lot was incorrectly packaged with Enfit extension sets.

To resolve this issue, Aveanna is sending replacement legacy extension sets to our patients to substitute the Enfit versions. No further action is required to receive these replacement products.

If you have questions about the recalled products, please contact Applied Medical Technology directly at 440-717-4000.

• Aveanna Patient Communication

Reckitt/Mead Johnson Nutrition Recalls Select Batches of Nutramigen Hypoallergenic Infant Formula Powder

On December 30, 2023, Reckitt/Mead Johnson Nutrition (MJN) voluntarily recalled select batches of Nutramigen Powder in 12.6 and 19.8 oz cans from the U.S. market due to a potential contamination with the Cronobacter sakazakii bacteria in product samples originating from outside of the United States.

The impacted Nutramigen product samples were manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the product samples, it is believed that much, if not all, have already been consumed. There are also no reports of illnesses or adverse events to date.

Consumers are advised to check the batch number on the bottom of the can and dispose of any affected products. The recalled product batches are ZL3FRW, ZL3FPE, ZL3FXJ, ZL3FQD, ZL3FMH, ZL3FHG with a UPC code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025.” If your product is not listed or does not have any of these lot numbers, it is not subject to the recall. To identify whether you have any of these formulas, please click below for additional information:

• FDA Safety Communication
• Reckitt/Mead Johnson Recall Notice
• Aveanna Patient Communication

Abbott and Lyons Magnus Product Recall

On August 10th, 2022, Abbott announced that Lyons Magnus, a third-party manufacturer for Abbott, expanded its voluntary recall initiated on July 28th, 2022 to include Ensure Harvest, PediaSure Harvest, and additional lots of Club Pack Glucerna Original Vanilla, Chocolate, and Strawberry in 8 fluid oz cartons.

If your products/lot numbers are listed, please dispose of them immediately. If your product is not listed or does not have any of these lot numbers, it is not subject to the recall. To identify whether you have any of these formulas please click below and review the instruction guides in the Abbott Recall Letter.

• Abbott and Lyons Magnus Recall – Aveanna Patient Communication
• Abbott Recall Notice

Kate Farms Formula Recall

As your dedicated enteral provider, we have an important update regarding a formula recall that may impact you. On July 28, 2022, Kate Farms issued a voluntary recall on specific lot numbers of Kate Farms Pediatric Standard 1.2 Vanilla products that were in the market between June 27, 2022, and July 27, 2022.

This recall has been expanded to include additional products and lot numbers. If your products/lot numbers are listed, please dispose of them immediately. If your product is not listed or does not have any of these lot numbers, it is not subject to the recall. To identify whether you have any of these formulas, please click below for additional information:

• Kate Farms Recall – Aveanna Patient Communication
• Kate Farms Recall Notice

Abbott Powder Formula Recall

As your dedicated enteral provider, we have an important update for you regarding Abbott powder formulas. On February 17th, 2022, Abbott issued a voluntary recall of specific powder formulas, including Similac, Alimentum and EleCare, manufactured at the Sturgis, Michigan plant. The products under recall have a multi-digit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after. Due to the high call volume related to this recall, our hold times are longer than normal.

Abbott Recall Notice

This recall is due to four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. Please reach out to Abbott for additional information related to this recall.

• Alternatives to Elecare and Mixing Directions