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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K971920
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FDA Recall
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Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE ... 2 04/14/2016 Customed, Inc
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical proc... 2 04/14/2016 Customed, Inc
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Us... 2 04/14/2016 Customed, Inc
GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedu... 2 09/03/2015 Customed, Inc
GOWN POLYREINF XLGE TOWEL/W 24/CS Used by medical staff to perform surgical procedures and ... 2 09/03/2015 Customed, Inc
SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical procedures and ... 2 09/03/2015 Customed, Inc
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedu... 2 09/03/2015 Customed, Inc
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedu... 2 09/03/2015 Customed, Inc
Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care proc... 2 09/03/2015 Customed, Inc
GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient... 2 09/03/2015 Customed, Inc
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