Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack
Summary
The FDA issued a Class II for Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number D by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-3003-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
Lot/Code Info: DYNJ17400B, Lot Number 23ABV075; DYNJ17400B, Lot Number 23ABV141; DYNJ17400B, Lot Number 22KBA557; DYNJ17400B, Lot Number 22GBJ307; DYNJ17400B, Lot Number 22DBU457; DYNJ32049A , Lot Number 19AKB211 ; DYNJ32049A , Lot Number 19CKA247 ; DYNJ44987G , Lot Number 21FBJ607 ; DYNJ44987G , Lot Number 21IBE237 ; DYNJ44987G , Lot Number 21KBA883 ; DYNJ44987G , Lot Number 21LBO984 ; DYNJ44987G , Lot Number 22CBN087 ; DYNJ44987G , Lot Number 20BBQ959 ; DYNJ44987G , Lot Number 20FBI170 ; DYNJ44987G , Lot Number 20JBL731 ; DYNJ44987G , Lot Number 21ABF141 ; DYNJ44987G , Lot Number 21CBF976 ; DYNJ44987G , Lot Number 21DBW445 ; DYNJ66288, Lot Number 20DBE878
Reason for Recall
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3003-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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