FDA Device recall Z-1069-2023
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOF…
- FDA Device
- Class II
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOF… by Medline Industries Northfield, citing sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1069-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-17 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
Reason
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Identifiers
| code_info | a. BREAST BIOPSY PACK-LF, Item Number: DYNJ0160598B, Case UDI/GTIN: 40889942051930, Unit UDI/GTIN: 10889942051939, Lot…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; e. SOFT TISSUE PACK, Item Number: DYNJ68311, Case UDI/GTIN: 40193489821933, Unit UDI/GTIN: 10193489821932, Lot Number: 22JBL797,22GBV060; f. HEMORRHOID PACK, Item Number: DYNJ69404, Case UDI/GTIN: 40193489936620, Unit UDI/GTIN: 10193489936629, Lot Number: 22HBI624; g. RECTAL, Item Number: DYNJ901758G, Case UDI/GTIN: 40193489979696, Unit UDI/GTIN: 10193489979695, Lot Number: 22JBQ935; h. BREAST, Item Number: DYNJ905525C, Case UDI/GTIN: 40195327122943, Unit UDI/GTIN: |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1069-2023%22
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