Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device (surgical trays) where sterile blades may puncture sterile packaging, creating a risk of contamination. No illnesses or injuries have been reported, but the potential for harm exists in surgical applications where sterility is critical, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling sterile procedural trays used in surgical and medical procedures. The recall affects multiple tray types including breast biopsy packs, laparotomy packs, hemorrhoid packs, and rectal packs, totaling 200 cases (858 units).
The reason for the recall is that sterile blades contained within the procedural trays have the potential to puncture the outer foil layer of the sterile packaging. This could compromise the sterility of the trays and the instruments they contain.
The affected trays have been distributed worldwide, including to the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. Specific lot numbers are identified for each tray type.
The FDA has classified this as a Class II recall. No illnesses or injuries have been reported. Consumers and healthcare facilities with affected trays should contact Medline Industries for instructions on returning or replacing the products.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: a. 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
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Trays
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a. BREAST BIOPSY PACK-LF
- Item Number: DYNJ0160598B
- Case UDI/GTIN: 40889942051930
- Unit UDI/GTIN: 10889942051939
- Lot Number: 22IDB852
- b. BREAST BIOPSY PACK
- Item Number: DYNJ45087C
- Case UDI/GTIN: 40195327044764
- Unit UDI/GTIN: 10195327044763
- Lot Number: 22JBO180
- c. LAPAROTOMY PACK
- Item Number: DYNJ55654B
- Case UDI/GTIN: 40193489956727
- Unit UDI/GTIN: 10193489956726
- Lot Number: 22JDA974
- d. BREAST PACK
- Item Number: DYNJ56546C
- Case UDI/GTIN: 40195327231164
- Unit UDI/GTIN: 10195327231163
- Lot Number: 22JBE655
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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