MaxGuard recallZ-1755-2022 · Carefusion · initiated Aug 1, 2022

Why it was recalled

Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

FDA root cause category: Error in labeling

What the company is doing

On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they were asked to provide a a list of customers who received affected devices. The distributor response form has a check box if the distributor declines to provide a customer list to the recalling firm because they have notified customers about the correction-recall. A copy of the customer communication was provided to the distributor. If customers or distributors require additional assistance they are aske to call 1-844-823-5433, Mon-Fri 8:00 AM - 5:00 PM CT or [email protected]

Recall details

Recall number

Z-1755-2022

Status

Open, Classified

Initiated by the company

Aug 1, 2022

Posted by the FDA

Sep 13, 2022

Recalling firm

Carefusion

Quantity

37,550

Product code

FPA

FDA submissions

K051499

Distribution

US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN

Product description

BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• MaxGuard MFS141

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall40 reports

Product lines

• MaxGuardBD Switzerland Sàrl · 49 models · 780 reports · 11 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 90707).

• Z-1752-2022 · Open, Classified
  BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
• Z-1753-2022 · Open, Classified
  BD MaxGuard Extension Set, REF: ME1069
• Z-1754-2022 · Open, Classified
  BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
• Z-1756-2022 · Open, Classified
  BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
• Z-1757-2022 · Open, Classified
  BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
• Z-1758-2022 · Open, Classified
  BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
• Z-1759-2022 · Open, Classified
  BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
• Z-1760-2022 · Open, Classified
  BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433