Reported Feb 15, 2023 · Ongoing

Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK…

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Sterile Procedural Trays
  • labeled as the followinga. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Lot codes and dates

9 of 9 products

Products covered by this recall
Model / numberBarcodesProduct as published
1088994205193940889942051930BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/ , Lot Number: 22IDB852
1019532704476340195327044764BREAST BIOPSY PACK, Item Number: DYNJ45087C, Case UDI/GTIN: 40195327044764, Unit UDI/ , Lot Number: 22JBO180
1019348995672640193489956727LAPAROTOMY PACK, Item Number: DYNJ55654B, Case UDI/GTIN: 40193489956727, Unit UDI/ , Lot Number: 22JDA974
1019532723116340195327231164BREAST PACK, Item Number: DYNJ56546C, Case UDI/GTIN: 40195327231164, Unit UDI/ , Lot Number: 22JBE655
1019348982193240193489821933SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/ , Lot Number: 22JBL797,22GBV060
1019348993662940193489936620HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/ , Lot Number: 22HBI624
1019348997969540193489979696RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/ , Lot Number: 22JBQ935
1019532712294240195327122943BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/ , Lot Number: 22JMF862,22HMH312
1019532709269640195327092697BREAST, Item Number: DYNJ906000B, Case UDI/GTIN: 40195327092697, Unit UDI/ , Lot Number: 22IBR879
Amount recalled
200 cases (858 units)

This recall covers 38 products

The agency filed one notice per product. You are reading one of them; the other 37 are below.

25 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.