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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92910

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
B. Braun Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02

Z-2643-2023
Recall number
Z-2643-2023
Initiated
August 07, 2023
Classification
Class II
Status
Ongoing
Recalling firm
B. Braun Medical, Inc.
Quantity
534,000 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile blister packaging may be damaged, and sterility may be compromised

Code information

UDI-DI: 04046955597031 Lot Numbers: 22M28C8, 23A09C8

Distribution pattern

US Nationwide distribution in the state of VA.

device · product 2 of 2

B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02

Z-2644-2023
Recall number
Z-2644-2023
Initiated
August 07, 2023
Classification
Class II
Status
Ongoing
Recalling firm
B. Braun Medical, Inc.
Quantity
604,800 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterility may be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile blister packaging may be damaged, and sterility may be compromised

Code information

UDI-DI: 04046955597185 Lot Numbers: 22M21C8, 23A09C8

Distribution pattern

US Nationwide distribution in the state of VA.