Z-0051-04

propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no...

Name: Z-0051-04 propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no...
Creator: Propper Mfg Co Inc
Published: 2002-08-09
License: https://open.fda.gov/license/

Propper Mfg Co Inc / initiated 2002-08-09 / Terminated

FDA source

Propper Mfg Co Inc began a recall of propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm... on 2002-08-09. The reason FDA records is "Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0051-04
Status: Terminated
Initiated: 2002-08-09
Posted: 2003-10-24
Terminated: 2003-10-23
Recalling firm: Propper Mfg Co Inc
Product: propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.
Product code: G-IO
Reason for recall: Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.
FDA root cause: Other
Action: On 8/9/02, Propper faxed a 'Request for Return' of the product to the consignees advising them of the problem and that a replacement will be sent for all returned product. On 11/27/02, Propper faxed a second 'Request for Return of Product' to its consignees. The firm destroyed the recovered and held stock.
Quantity in commerce: 178 boxes
Distribution: Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA.
Product codes and lots: Reorder No. 043021, Lot # C0402

Product code G-IO

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)