(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ9
Summary
The FDA issued a Class II for (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) M by MEDLINE INDUSTRIES, LP - Northfield. Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length..
Details
Source
Device Recall
External ID
Z-0533-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Lot/Code Info: (1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.
Quantity Affected: 360 kits
Reason for Recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Distribution
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-15
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 162 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0533-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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