(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Reported: December 4, 2024 Initiated: October 15, 2024 #Z-0533-2025
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.
Reason for Recall
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 360 kits
- Distribution
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 360 kits.
Why was this product recalled? ▼
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0533-2025.
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