Z-1120-2019Class II

Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07

Name: Z-1120-2019 Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Creator: Becton Dickinson & Company
Published: 2019-03-05
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-03-05 / Terminated

FDA source

Becton Dickinson & Company began a recall of Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07 on 2019-03-05. FDA classified it as Class II and gives the reason as "The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1120-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-05
Posted: 2019-04-10
Terminated: 2020-07-15
Recalling firm: Becton Dickinson & Co
Product: Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
Product code: FPA Set, Administration, Intravascular
Reason for recall: The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.
FDA root cause: Under Investigation by firm
Action: On March 5, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that product was being recalled due to reports of kinked tubing which can lead to occlusion of the sets and reduction in the rate of infusion. Please Take the Following Actions: 1. Immediately review your inventory for the specific Catalogues (Ref) and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material, so that BD may acknowledge your receipt of this notification and provide product replacement. If you require further assistance, please contact: Customer Advocacy Phone: 888-812-3266 Phone hours: 24 hours a day, 7 days a week Email: [email protected]
Quantity in commerce: 21220 total cases of 20
Distribution: Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.
Product codes and lots: 18105594 18105595 18105596 18105597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10
Z-1121-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10

Product code FPA

K931173Class IIPrimary Admin Set W/univ Sp-Man Below/abv Pump ChImed Corp. / cleared 1994-04-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)