# FDA recall Z-1068-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2022-11-17.

## Product

Sterile Procedural Trays, labeled as the following:    a. PORT/TRACH INSERTION CDS-3  b. RESIDENT DERM SURG PACK  c. THROMBECTOMY PACK-LF  d. AV FISTULA PACK  e. AV SHUNT PACK-LF  f. RR-VP SHUNT PACK-LF  g. VEIN HARVESTING PACK-LF  h. AV FISTULA PACK-LF  i. PK, GEN-BARIATRIC  j. VEIN PACK  k. VENOUS ACCESS PACK-LF  l. VENOUS ACCESS PACK  m. VASCULAR ACCESS PACK  n. ARTERIOGRAM PACK  o. AV FISTULA/GRAFT INSER PK  p. VEIN ABLATION PACK  q. PORT PACK  r. MINOR VASCULAR  s. FISTULA PACK  t. AV FISTULA-LF  u. AV FISTULA  v. PORT VENOUS ACCESS  w. AV FISTULA

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

## Key facts

- **Recall number:** Z-1068-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-17
- **Report date:** 2023-02-15

- **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-1068-2023

## Citation

> AI Analytics. FDA recall Z-1068-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1068-2023. Source: US FDA. Licensed CC0.

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