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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78369

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

Open FDA event record

Event summary

Timeline bucket
September 05, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Dossier provenance

Source snapshots represented here

  • openFDA Drug 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.

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

4 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.

drug · product 1 of 4

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.

D-0157-2018
Recall number
D-0157-2018
Initiated
September 05, 2017
Classification
Class II
Status
Terminated
Quantity
29,232 1 oz bottle

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Lot: Z516

Distribution pattern

IA, WI

drug · product 2 of 4

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583

D-0158-2018
Recall number
D-0158-2018
Initiated
September 05, 2017
Classification
Class II
Status
Terminated
Quantity
22,080 4 oz bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Lot: A225

Distribution pattern

IA, WI

drug · product 3 of 4

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585

D-0159-2018
Recall number
D-0159-2018
Initiated
September 05, 2017
Classification
Class II
Status
Terminated
Quantity
130,740 16 oz bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Lot: A259, A260, EXP 05-26-2018; A301, 06-23-2018; B117, B118, EXP 03-02-2019; C005, EXP 01-09-2020; C219, EXP 05-24-2020; Z521, EXP 10-06-2017

Distribution pattern

IA, WI

drug · product 4 of 4

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587

D-0160-2018
Recall number
D-0160-2018
Initiated
September 05, 2017
Classification
Class II
Status
Terminated
Quantity
96,828 32 oz bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017.

Distribution pattern

IA, WI