Home › Device types › FRL
Fiber, Medical, Absorbent
FDA product code FRL · Class 1 · General Hospital
1,130
Registered devices
281
Adverse events
6
Recalls
19
510(k) clearances
Devices with this code
BGEcare Non-sterile Non-woven Sponge — Henan Zhende Medical Products Co., Ltd.A Plus — A PLUS INTERNATIONAL INC.Water plus Microfiber Wipe, Texwipe — CYGNUS MEDICAL L.L.C.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCEncompass — Encompass Group, L.L.C.A Plus — A PLUS INTERNATIONAL INC.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCCurity — Cardinal Health, Inc.Curity — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCTOWEL PERVAL — STANDARD TEXTILE CO., INC.MEDLINE — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCBGE care — Henan Zhende Medical Products Co., Ltd.Bioseal Inc. — BIOSEALU.S. Cotton — U.S. COTTON, LLCNOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCCurity — Cardinal Health 200, LLCOR TOWEL PERVAL — STANDARD TEXTILE CO., INC.Tally Surgical Solution — Tally Surgical, Inc.N/A — TETRA MEDICAL SUPPLY CORP.Bioseal Inc. — BIOSEAL
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-25 | Medline Industries Inc | Potential for mold contamination (Aspergillus vadensis) |
| 2017-12-11 | Medical Action Industries Inc | Product sterility potentially compromised. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2009-07-21 | Coloplast Corp Skin Care Div | Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion o |
| 2006-02-09 | 3M Company / Medical Division | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as st |
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