Exact FDA event identifier

Event 66060

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

Event summary

Timeline bucket: August 12, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Churchill Medical Systems, 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

Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

Z-2251-2013

Recall number: Z-2251-2013
Initiated: August 12, 2013
Classification: Class II
Status: Terminated
Recalling firm: Churchill Medical Systems, Inc.
Quantity: 13100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Microbore tubing disconnecting from male luers on the extension sets.

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

Microbore tubing disconnecting from male luers on the extension sets.

Code information

1203117, 1206030, 1212111, 1304133, 130516

Distribution pattern

Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

device · product 2 of 2

Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep, 3ml Applicator W/Insert 1 Pkg. Alcohol Swabsticks (3/Pkg.) 1 14" Extension Set W/Bionector 2 Dressing Sponges, 2" X 2" 1 Foam Strip, 8/5cm X 1cm 1 3M* Tegaderm * IV Dressing W/CHG, 2 1/2" X 4 1/2" * Vygon MFG Dover, NH 03820*"

Z-2252-2013

Recall number: Z-2252-2013
Initiated: August 12, 2013
Classification: Class II
Status: Terminated
Recalling firm: Churchill Medical Systems, Inc.
Quantity: 3040

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Microbore tubing disconnecting from male luers on the extension sets.

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

Microbore tubing disconnecting from male luers on the extension sets.

Code information

Lot Numbers: 1303022, 1304065

Distribution pattern

Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.