# FDA recall Z-1611-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2025-03-03.

## Product

Medline Convenience kits used for various procedures:  1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L;   2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P;   3) VUWC OB PACK, Model Number: DYNJ64017B;   4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A;   5) PACK VAGINAL DELIVERY, Model Number: HM190A;   6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B;   7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209;   8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B;   9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C;   10) VAGINAL DEL PK, Model Number: DYNJ65689;   11) PK,L&D-VAG DEL, Model Number: DYNJ43737D;   12) L&D PACK-LF, Model Number: DYNJ0731657M;   13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B;   14) VAD ACCESS, Model Number: DYNJ24276C;   15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304;   16) VAGINAL DELIVERY CDS, Model Number: CDS982762I;   17) VAGINAL DELIVERY, Model Number: DYNJ903796C;   18) VAGINAL DELIVERY PACK, Model Number: DYNJ4

## Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

## Key facts

- **Recall number:** Z-1611-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-03
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1611-2025

## Citation

> AI Analytics. FDA recall Z-1611-2025. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-1611-2025. Source: US FDA. Licensed CC0.

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