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Recall Observatory FDA recall evidence

Device product

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F

Z-3060-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94583
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-3060-2024

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: CDS983874F , Lot Number 19JDA152 ; CDS983874F , Lot Number 19KDC441 ; CDS983874F , Lot Number 20ADB656 ; CDS983874F , Lot Number 20BDC710 ; CDS983874F , Lot Number 20EDA493 ; CDS983874F , Lot Number 20FDB761 ; CDS983874F , Lot Number 20JDC993 ; CDS983874F , Lot Number 21ADB720 ; CDS983874F , Lot Number 21DDA797 ; CDS983874F , Lot Number 21FDB765 ; CDS983874F , Lot Number 21HDA924 ; CDS983874F , Lot Number 21KDA957 ; CDS983874F , Lot Number 22BDA224 ; CDS983874F , Lot Number 22DDB013 ; CDS983874F , Lot Number 22GDA535 ; CDS983874F , Lot Number 22HDC091 ; CDS983874F , Lot Number 22JDA459 ; CDS983874F , Lot Number 23ADB076 ; CDS983874F , Lot Number 23DDA408 ; CDS983874F , Lot Number 23FDB732 ; CDS983874F , Lot Number 23IDA600 ; CDS983874F , Lot Number 23LDA901 ; CDS983874F , Lot Number 24CDA648 ; CDS984080F, Lot Number 23FBF618; CDS984080F, Lot Number 23EBN989; CDS984080F, Lot Number 23BBR987; CDS984080F, Lot Number 23ABH436; CDS984080F, Lot Number 23ABF537; CDS984080F, Lot Number 22IBR063; CDS984080F, Lot Number 22HBJ841

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.