Z-2027-2011

Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a...

Name: Z-2027-2011 Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a...
Creator: Hospira Inc.
Published: 2011-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-03-28 / Terminated / root cause: sterility

FDA source

Hospira Inc. began a recall of Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of... on 2011-03-28. The reason FDA records is "There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2027-2011
Status: Terminated
Initiated: 2011-03-28
Posted: 2011-04-19
Terminated: 2012-05-09
Recalling firm: Abbott Medical
Product: Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
Root cause tag: sterility
FDA root cause: Other
Action: The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at ([email protected]).
Quantity in commerce: 61,150 sets
Distribution: Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.
Product codes and lots: List No. 13744-28, lots 930345H, 931425H, 932785H

Product code KDC

K103224Class IIHospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe TubingHospira, Inc. / cleared 2011-01-07

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)