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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88725

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 10, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD 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

1 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 1

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE

Z-0155-2022
Recall number
Z-0155-2022
Initiated
May 10, 2018
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
933,518 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product has a lack of sterility assurance

Code information

a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402 b. 081-101GE, Serial Numbers: 1570343301 c. 081-101GEE, Serial Numbers: 1470293701, 1570343401 d. 081-101NE, Serial Numbers: 1570323801, 1570341001, 1570342701, 1570344101, 1660688101, 1670354301 e. 081-102NE, Serial Numbers: 1660636701 f. 081-102RE, Serial Numbers: 1660636601 g. 089-101E, Serial Numbers: 1570316801, 1570342601, 1570344601, 1660670001, 1670347801, 1670355201, 1670359701 h. 888-101NE, Serial Numbers: 1570343001 i. 081-102GEE, Serial Numbers: 1660636901 j. 888-101BE, Serial Numbers: 1570319201, 1570343101, 1570344201, 1670348101, 1670348102 k. 888-101GE, Serial Numbers: 1570343201, 1660688201 l. 888-101GEE, Serial Numbers: 1470312301, 1570343501 m. 081-101RE, Serial Numbers: 1570342901 n. 081-102GE, Serial Numbers: 1660637101 o. 081-102BE, Serial Numbers: 1570316901, 1660637501 p. 888-101RE, Serial Numbers: 1570344301, 1670356201

Distribution pattern

International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.