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Recall Observatory FDA recall evidence

Device product

Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

Z-2630-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94582
Status
Ongoing
Classification
Class II
Quantity
1,679,067 units in total
Official record key
device-enforcement:Z-2630-2024

Official wording

Reason: 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.

Code information: DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.