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FDA DevicesClass II

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Veröffentlicht: 29. April 2026Rückruf-ID: Z-1921-2026Kategorie: MedizinprodukteLand: Vereinigte Staaten
US
Medical DeviceFDA DevicesUSUS

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Recalling Firm: Windstone Medical Packaging, Inc.

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Mitteilung übersetzenTranslate notice text, hazard warnings, and descriptions into any supported language.

Grund für den Rückruf / Gefahr

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).

Produktbeschreibung & Identifikation

Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Additional Source Details

FieldValue
CityBillings
StateMT
Event id98659
Address 11602 4th Ave N
Address 2N/A
Code infoUDI-DI: B098AMS14994A0; Lot Numbers: 224792 228566 230105 230853 234209
Postal code59101-1521
Report date20260429
Product typeDevices
Product quantity520 units
Reason for recallThe product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260311
Initial firm notificationE-Mail
Center classification date20260422

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Übersicht

  • Rückrufendes UnternehmenWindstone Medical Packaging, Inc.
  • StatusOngoing
  • RisikostufeClass II
  • DistributionUS Nationwide distribution in the states of GA, OR, TN, and WA.
Recall Hazard Severity
High Alert (Class I)
Offizielle Behördenwarnung

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🚨 SAFETY ALERT: Windstone Medical Packaging, Inc. - Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

Check if your household is affected:
https://therecallfile.com/de/recalls/custom-convenience-kits-pre-op-kit-ns-part-number-ams14994a/FDA-Z-1921-2026
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