Z-1228-2011

Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal...

Name: Z-1228-2011 Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal...
Creator: Thomas Medical Products Inc
Published: 2010-12-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2010-12-16 / Terminated / root cause: packaging

FDA source

Thomas Medical Products Inc began a recall of Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during... on 2010-12-16. The reason FDA records is "Compromised sterility/weak or open seals". 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-1228-2011
Status: Terminated
Initiated: 2010-12-16
Posted: 2011-02-14
Terminated: 2012-08-08
Recalling firm: Merit Medical Systems, Inc.
Product: Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contamination Sleeve part no. CON-006-02; Acuity Bleedback Control Valve part no. CSP-001-00; Acuity Rotating Hemostasis Valve part no. CSP-002-01; Acuity Universal Cutter part no. CSP-003-00; Acuity Universal Cutter part no. CSP-003-01.
Product code: DQY Catheter, Percutaneous
Reason for recall: Compromised sterility/weak or open seals.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.
Quantity in commerce: 28,679 for all products
Distribution: Distribution Nationwide USA and Germany.
Product codes and lots: Contamination Sleeve part no. CON-006-02, lot no. S32943; Acuity Bleedback Control Valve part no. CSP-001-00, lot no. Z0000040; Acuity Rotating Hemostasis Valve part no. CSP-002-01, lot no. Z0000036; Acuity Universal Cutter part no. CSP-003-00, lot numbers Z0000038 and Z0000039; Acuity Universal Cutter part no. CSP-003-01, lot number Z0000054.

Product code DQY

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)