FDAJune 11, 2024device

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and cath...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

What to do

FDA enforcement status: Ongoing

Brands named

merit medical systemsmeritmerit medical

UPCs

008844504950490088445049505600884450495087008844504955680088445049549000884450495506

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and cath... — Recall Details · AllClear