Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75781

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

Open FDA event record

Event summary

Timeline bucket
November 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization

Z-0771-2017
Recall number
Z-0771-2017
Initiated
November 22, 2016
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
102,843 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

Code information

Product Code: 10096080, Lot number: 74F1501853 (8 FR); Product Code: 10096120, Lot numbers: 74E1602795, 74F1503201, 74G1600723 & 74J1500576 (12 FR); Product Code: 10096140, Lot numbers: 74A1600023, 74A1601105, 74A1602234, 74D1602007, 74E1602235, 74E1602796, 74F1501855, 74G1600486, 74H1500530 & 74L1500363 (14 FR); Product Code: 10096100, Lot numbers: 74A1600799, 74A1600800, 74A1602236, 74A1603122, 74D1600231, 74D1600923, 74D1601540, 74D1602136, 74E1600845, 74E1601768, 74E1602237, 74F1501857, 74F1501962, 74F1601966, 74F1601988, 74H1500534, 74H1500978, 74J1501157, 74K1502306, 74L1500364, 74L1501303, 74L1501938, 74M1500227 and 74M1501087 (10 FR) and Product Code: 10096160, Lot numbers: 74A1600024, 4A1600801, 74A1601106, 74A1603123, 74D1601541, 74E1600846, 74E1602797, 74G1600724, 74H1500979, 74J1501158, 74K1501837, 74L1501202 &74L1501939 (16 FR).

Distribution pattern

Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.