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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90438

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

Open FDA event record

Event summary

Timeline bucket
May 31, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Fresenius Medical Care Holdings, 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

NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0

Z-1370-2022
Recall number
Z-1370-2022
Initiated
May 31, 2022
Classification
Class II
Status
Ongoing
Quantity
656 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

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

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Code information

UDI-DI: (01) 000840861101696 (17) 240331 (10) 22CTAC106 Lot Number: 22CTAC106 Exp Date: 2024-03-31

Distribution pattern

Natiowide

device · product 2 of 2

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

Z-1371-2022
Recall number
Z-1371-2022
Initiated
May 31, 2022
Classification
Class II
Status
Ongoing
Quantity
163 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

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

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Code information

UDI-DI: (01) 10840861101757 (17) 240331 (10) 22CTAC102 Lot Number: 22CTAC102 Exp Date: 2024-03-31

Distribution pattern

Natiowide