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U.S. Department of Health and Human Services

Class 2 Device Recall calmark(R)

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  Class 2 Device Recall calmark(R) see related information
Date Initiated by Firm August 09, 2002
Date Posted October 24, 2003
Recall Status1 Terminated 3 on October 23, 2003
Recall Number Z-0051-04
Recall Event ID 26844
Product Classification unknown device name - Product Code G-IO
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.
Code Information Reorder No. 043021, Lot # C0402
Recalling Firm/
Manufacturer		 Propper Mfg Co Inc
36-04 Skillman Avenue
Long Island City NY 11101
For Additional Information Contact Frank E. Platko
718-392-6650
Manufacturer 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 Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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