# FDA recall Z-1088-2023

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

## Product

Sterile Procedural Trays, labeled as the following:      a.	AV SHUNT CDS  b.	ZALE V-P SHUNT CDS  c.	NEURO CDS-LF  d.	MAJOR NEURO  e.	NEURO PACK-LF  f.	CUSTOM NEURO PACK-LF  g.	NEURO PACK-LF  h.	NEURO PACK-LF  i.	NEURO PACK-LF  j.	NEURO PACK-LF  k.	NEURO/LAMINECTOMY BASIN PK-LF  l.	U H S NEURO PACK SC  m.	NEURO PACK-CELEBRATION  n.	NEURO PACK  o.	NEURO BASIN PACK-LF  p.	NEURO PACK  q.	MAJOR NEURO PK-LF  r.	NINOR NEURO PK-LF  s.	NEURO VP SHUNT/VAGAL NERVE-RF  t.	NEURO PACK-LF  u.	NEURO PACK  v.	CRANIOTOMY  w.	PEDIATRIC NEURO PACK  x.	NEURO MATRIX PACK  y.	ACOUSTIC NEUROMA PACK-LF  z.	MAJOR NEURO PACK-LF  aa.	SCRIPPS SW NEURO PACK-LF  bb.	NEURO PACK  cc.	GENERAL PACK  dd.	NEURO PK  ee.	NEURO PACK  ff.	NEURO PACK  gg.	NEURO PACK  hh.	NEURO PACK-LF  ii.	NEURO PACK  jj.	NEURO PACK  kk.	NEURO PACK  ll.	NEURO PACK  mm.	CRANIOTOMY PACK  nn.	PK, NEURO-MINOR  oo.	NEURO PACK  pp.	NEURO PACK  qq.	NEURO PACK  rr.	PK, NEURO-MINOR  ss.	NEURO BASIC  tt.	NEURO BASIC  uu.	CRANIOTOMY PACK (CRSJE)227-LF  v

## 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-1088-2023
- **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-1088-2023

## Citation

> AI Analytics. FDA recall Z-1088-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1088-2023. Source: US FDA. Licensed CC0.

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