FDA Medical Device Recalls (openFDA)
Propper Mfg Co Inc: 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.
- Recall number
- Z-0051-04
- 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.
- Status
- Terminated
- Initiated
- 2002-08-09
- Posted
- 2003-10-24
- Terminated
- 2003-10-23
- Reason
- 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.
- 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
- 178 boxes
- Distribution
- Distributors located in TX, UT, ID, IL, IA, IN, MN, WI, OH, CT, MO, PA, VA.
- Lot, serial or model codes
- Reorder No. 043021, Lot # C0402
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- G-IO
- Firm FEI
- 2410251
- Firm city
- City
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28