PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C

Reported: August 28, 2024 Initiated: March 22, 2024 #Z-2701-2024

Product Description

Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C

Reason for Recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Details

Units Affected
26096 units
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO KIT, REF DYKE1921A, d) PACEMAKER, REF DYNJ901681D, e) UPPER ENDO KIT, REF DYKE1922A, f) VASCULAR, REF DYNJ905515D, g) VASCUALR, REF DYNJ902387K, h) VASCULAR III, REF DYNJS2035C. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 26096 units.
Why was this product recalled?
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2701-2024.