Z-2293-2014Class II

CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU...

Name: Z-2293-2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU...
Creator: ICU Medical, Inc.
Published: 2014-08-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-08-05 / Terminated / root cause: packaging

FDA source

ICU Medical, Inc. began a recall of CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots... on 2014-08-05. FDA classified it as Class II and gives the reason as "ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2293-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-05
Posted: 2014-08-20
Terminated: 2015-02-26
Recalling firm: Abbott Medical
Product: CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Product code: GAX Tourniquet, Nonpneumatic
Reason for recall: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Root cause tag: packaging
FDA root cause: Other
Action: An Urgent recall letter dated 8/5/2014 was sent to all customers who purchased the BD PosiFlush SF Saline Flush Syringe 10ml. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM to 4:00PM PST at (866) 829-9025 and select option 8, or email [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or email to [email protected].
Quantity in commerce: 300 units
Distribution: Nationwide Distribution - USA including AL and MD.
Product codes and lots: Lot No. 2704633, 2705206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2293-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20
Z-2294-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20
Z-2295-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20

Product code GAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)